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overall survival lapatinib breast cancer

Michael P Chu, J Randolph Hecht, Dennis Slamon, Zev A Wainberg, Yung-Jue Bang, Paulo M Hoff, Alberto Sobrero, Shukui Qin, Karen Afenjar, Vincent Houe, Karen King, Sheryl Koski, Karen Mulder, Julie Price Hiller, Andrew Scarfe, Jennifer Spratlin, Yingjie J Huang, Saba Khan-Wasti, Neil Chua, Michael B Sawyer
Importance: Capecitabine is an oral cytotoxic chemotherapeutic commonly used across cancer subtypes. As with other oral medications though, it may suffer from drug interactions that could impair its absorption. Objective: To determine if gastric acid suppressants such as proton pump inhibitors (PPIs) may impair capecitabine efficacy. Design, Setting, and Participants: This secondary analysis of TRIO-013, a phase III randomized trial, compares capecitabine and oxaliplatin (CapeOx) with or without lapatinib in 545 patients with ERBB2/HER2-positive metastatic gastroesophageal cancer (GEC); patients were randomized 1:1 between CapeOx with or without lapatinib...
October 13, 2016: JAMA Oncology
Kohei Shitara, Atsushi Ohtsu
In recent years, various new agents have been investigated for the treatment of advanced gastric cancer (AGC). The anti-HER2 antibody trastuzumab has been shown to prolong the overall survival of patients with HER2-positive AGC and has become a standard treatment. However, lapatinib, or ado-trastuzumab emtansine (T-DM1), did not show survival benefit in AGC, although it has shown remarkable efficacy for HER2-positive breast cancer. The efficacy of the anti-vascular endothelial growth factor receptor monoclonal antibody ramucirumab for pretreated gastric cancer is a milestone for antiangiogenic therapy for AGC...
October 2016: Journal of the National Comprehensive Cancer Network: JNCCN
Quang A Le, Yuna H Bae, Jenny H Kang
PURPOSE: The EMILIA trial demonstrated that trastuzumab emtansine (T-DM1) significantly increased the median profession-free and overall survival relative to combination therapy with lapatinib plus capecitabine (LC) in patients with HER2-positive advanced breast cancer (ABC) previously treated with trastuzumab and a taxane. We performed an economic analysis of T-DM1 as a second-line therapy compared to LC and monotherapy with capecitabine (C) from both perspectives of the US payer and society...
October 2016: Breast Cancer Research and Treatment
A Dias, W Claudino, R Sinha, C A Perez, D Jain
The Human Epidermal growth factor Receptor 2 (HER2) is a potent mediator of cellular growth and proliferation. It plays an important role in cardiac development and maintaining the physiologic function of an adult heart. Amplification of the HER2 gene, and the corresponding overexpression of the HER2 receptor, occurs in roughly 20% of breast tumors and is associated with a poor outcome. Molecular targeting of the HER2 receptor with the humanized monoclonal antibody, Trastuzumab has improved disease-free and overall survival in patients with both metastatic and early HER2-positive breast cancer...
August 2016: Critical Reviews in Oncology/hematology
Stefania Gori, Alessandro Inno, Valentina Rossi, Monica Turazza, Elena Fiorio, Alessandra Fabi, Giancarlo Bisagni, Jennifer Foglietta, Daniele Santini, Ida Pavese, Arianna Pellegrino, Alberto Zambelli, Patrizia Vici, Vita Leonardi, Sandro Barni, Silvana Saracchini, Giuseppe Bogina, Fabiana Marchetti, Simona Duranti, Gianluigi Lunardi, Filippo Montemurro
BACKGROUND: There are no validated predictive markers for lapatinib and capecitabine in patients with trastuzumab-resistant HER2 positive metastatic breast cancer. METHODS: Data of 148 consecutive patients treated with lapatinib and capecitabine from March 2007 to December 2013 were collected from 13 Italian institutions. Estimates of progression-free survival (PFS) and overall survival (OS) were obtained with the Kaplan-Meier method and compared with logrank test...
2016: PloS One
Caterina Fontanella, Elisa De Carlo, Marika Cinausero, Giacomo Pelizzari, Ilaria Venuti, Fabio Puglisi
Central nervous system (CNS) involvement from breast cancer (BC) has been historically considered a relatively rare event. However, the development of new therapeutic strategies with a better control of extra-cranial disease and a longer overall survival (OS) has determined an increased incidence of brain metastases. Patients with HER2-positive or triple negative BC have higher occurrence of CNS involvement than patients with luminal-like disease. Moreover, after development of brain metastases, the prognosis is highly influenced by biological subtype...
May 2016: Cancer Treatment Reviews
S Loibl, I Majewski, V Guarneri, V Nekljudova, E Holmes, E Bria, C Denkert, C Schem, C Sotiriou, S Loi, M Untch, P Conte, R Bernards, M Piccart, G von Minckwitz, J Baselga
BACKGROUND: The predictive value of PIK3CA mutations in HER2 positive (HER2+) breast cancer treated with neoadjuvant anti-HER2 and chemotherapy has been reported, but the power for subgroup analyses was lacking. PATIENTS AND METHODS: We combined individual patient data from five clinical trials evaluating PIK3CA mutations and associations with pathological complete response (pCR), disease-free survival (DFS) and overall survival (OS). Patients received either trastuzumab (T), lapatinib (L) or the combination T/L in addition to a taxane-based chemotherapy...
August 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Amir Sonnenblick, Evandro de Azambuja, Dominique Agbor-Tarh, Ian Bradbury, Christine Campbell, Yingjie Huang, Amylou C Dueck, Kathleen I Pritchard, Antonio C Wolff, Christian Jackisch, Istvan Lang, Michael Untch, Ian Smith, Frances Boyle, Binghe Xu, Henry Gomez, Edith A Perez, Martine Piccart, Hatem A Azim
BACKGROUND: Previously we have shown that early development of rash is associated with a higher chance of achieving pathological complete response to neoadjuvant lapatinib. In the current analysis, we investigate its impact on survival in the ALTTO phase III adjuvant trial. METHODS: In ALTTO, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomly assigned to adjuvant trastuzumab, lapatinib, their sequence, or their combination for a total duration of one year...
August 2016: Journal of the National Cancer Institute
Ahmad Awada, Ramon Colomer, Kenichi Inoue, Igor Bondarenko, Rajendra A Badwe, Georgia Demetriou, Soo-Chin Lee, Ajay O Mehta, Sung-Bae Kim, Thomas Bachelot, Chanchal Goswami, Suryanarayan Deo, Ron Bose, Alvin Wong, Feng Xu, Bin Yao, Richard Bryce, Lisa A Carey
Importance: Efficacious ERBB2 (formerly HER2 or HER2/neu)-directed treatments, in addition to trastuzumab and lapatinib, are needed. Objective: To determine whether neratinib, an irreversible pan-ERBB tyrosine kinase inhibitor, plus paclitaxel improves progression-free survival compared with trastuzumab plus paclitaxel in the first-line treatment of recurrent and/or metastatic ERBB2-positive breast cancer. Design, Setting, and Participants: In the randomized, controlled, open-label NEfERT-T trial conducted from August 2009 to December 2014 at 188 centers in 34 countries in Europe, Asia, Africa, and North America, 479 women with previously untreated recurrent and/or metastatic ERBB2-positive breast cancer were randomized to 1 of 2 treatment arms (neratinib-paclitaxel [n = 242] or trastuzumab-paclitaxel [n = 237])...
April 14, 2016: JAMA Oncology
S Michiels, L Pugliano, S Marguet, D Grun, J Barinoff, D Cameron, M Cobleigh, A Di Leo, S Johnston, G Gasparini, B Kaufman, M Marty, V Nekljudova, S Paluch-Shimon, F Penault-Llorca, D Slamon, C Vogel, G von Minckwitz, M Buyse, M Piccart
BACKGROUND: The gold standard end point in randomized clinical trials in metastatic breast cancer (MBC) is overall survival (OS). Although therapeutics have been approved based on progression-free survival (PFS), its use as a primary end point is controversial. We aimed to assess to what extent PFS may be used as a surrogate for OS in randomized trials of anti-HER2 agents in HER2+ MBC. METHODS: Eligible trials accrued HER2+ MBC patients in 1992-2008. A correlation approach was used: at the individual level, to estimate the association between investigator-assessed PFS and OS using a bivariate model and at the trial level, to estimate the association between treatment effects on PFS and OS...
June 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
S S Göksu, H Bozcuk, L Koral, B Çakar, S Gündüz, A M Tatlı, D Arslan, M Uysal, M Koçer, M Artaç, B Karabulut, H S Coşkun, M Özdoğan, B Savaş
CONTEXT: Introduction of trastuzumab, a recombinant monoclonal antibody against the extracellular domain of HER-2, is a cornerstone in the treatment of HER-2+ breast carcinoma. However, many cancers that have an initial response to trastuzumab will progress some time later. After progression on trastuzumab-based first-line treatment, there are several options. Although TDM-1 (Trastuzumab emtansine) has prolonged progression-free survival (PFS) and overall survival in patients previously treated with trastuzumab and taxane, it is still not available in Turkey...
October 2015: Indian Journal of Cancer
José Baselga, Gail D Lewis Phillips, Sunil Verma, Jungsil Ro, Jens Huober, Alice E Guardino, Meghna K Samant, Steve Olsen, Sanne L de Haas, Mark D Pegram
PURPOSE: HER2-positive breast cancer is heterogeneous. Some tumors express mutations, like activating PIK3CA mutations or reduced PTEN expression, that negatively correlate with response to HER2-targeted therapies. In this exploratory analysis, we investigated whether the efficacy of trastuzumab emtansine (T-DM1), an antibody-drug conjugate comprised of the cytotoxic agent DM1 linked to the HER2-targeted antibody trastuzumab, was correlated with the expression of specific biomarkers in the phase III EMILIA study...
August 1, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Masahiro Kashiwaba, Yoshinori Ito, Shintaro Takao, Hiroyoshi Doihara, Yoshiaki Rai, Kazumitsu Kanatani, Shigemitsu Takashima, Norikazu Masuda
OBJECTIVE: Trastuzumab emtansine significantly improved progression-free survival and overall survival when compared with lapatinib-capecitabine in pretreated human epidermal growth factor receptor 2-positive advanced breast cancer. However, data in Japanese populations are limited. METHODS: In the single-arm Phase II JO22997 study, Japanese patients with human epidermal growth factor receptor 2-positive inoperable locally advanced/recurrent or metastatic breast cancer previously treated with at least one prior chemotherapy regimen for locally advanced/recurrent or metastatic breast cancer and trastuzumab in any setting received 3...
May 2016: Japanese Journal of Clinical Oncology
Hazel Squires, Matt Stevenson, Emma Simpson, Rebecca Harvey, John Stevens
The National Institute for Health and Care Excellence (NICE) invited the manufacturer of trastuzumab emtansine (T-DM1) (Kadcyla(®); Roche) to submit evidence of its clinical and cost-effectiveness for treating human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane. The School of Health and Related Research Technology Appraisal Group (ScHARR-TAG) at the University of Sheffield were the independent Evidence Review Group (ERG) who produced a critical review of the company's submission to NICE...
July 2016: PharmacoEconomics
Christiane Thallinger, Istvan Lang, Cvetka Grasic Kuhar, Rupert Bartsch, Christian F Singer, Lubos Petruzelka, Bohuslav Melichar, Regina Knittelfelder, Thomas Brodowicz, Christoph Zielinski
BACKGROUND: Vinorelbine constitutes effective chemotherapy for metastatic breast cancer (MBC) and acts synergistically with trastuzumab in HER-2/neu positive disease. The present study was set out to evaluate the efficacy and safety of vinorelbine when combined with lapatinib, an anti-HER2 tyrosine-kinase inhibitor, as late-line regimen administered beyond previous disease progression on prior lapatinib in patients with HER-2/neu- positive MBC. METHODS: The CECOG LaVie study was designed as open-labeled, single-arm, multicenter phase II trial...
2016: BMC Cancer
Pooja Murthy, Kelley M Kidwell, Anne F Schott, Sofia D Merajver, Jennifer J Griggs, Jeffrey D Smerage, Catherine H Van Poznak, Max S Wicha, Daniel F Hayes, N Lynn Henry
Prior to availability of anti-HER2 therapies, HER2-positive metastatic breast cancer (MBC) was associated with a poor prognosis. Prospective randomized trials have demonstrated survival benefit from anti-HER2 treatments. Anecdotal observations have suggested that a small but meaningful fraction of patients with HER2-positive MBC may be "exceptional responders" with long survival. We hypothesized that demographic and/or clinicopathologic characteristics can be identified to distinguish short-term from long-term survivors...
February 2016: Breast Cancer Research and Treatment
Jurandyr M de Andrade, Luiz G O Brito, Elaine C D Moises, Andréa C Amorim, Liane Rapatoni, Hélio H A Carrara, Daniel G Tiezzi
Here, we describe the case of a patient diagnosed with locally advanced breast cancer 8 years ago. Her treatment course was neoadjuvant chemotherapy, followed by mastectomy and then adjuvant radiotherapy and trastuzumab (TTZ). During the use of adjuvant targeted therapy, an incidental pregnancy was diagnosed. Four years later, she developed bone and cerebral metastases, and since then, she has received courses of TTZ, capecitabine, lapatinib, and radiotherapy with intermittent control of the disease. Her 7-year-old son presents a normal physical and long-term neurological developmental curve according to specialized evaluation...
April 2016: Anti-cancer Drugs
Chee Khoon Lee, Lucy Davies, Val J Gebski, Sarah J Lord, Angelo Di Leo, Stephen Johnston, Charles Geyer, David Cameron, Michael F Press, Catherine Ellis, Sherene Loi, Ian Marschner, John Simes, Paul de Souza
PURPOSE: We examined the prognostic and predictive value of serum human epidermal growth factor 2 (HER2) extracellular domain (sHER2) in patients with advanced breast cancer treated with lapatinib using data from three randomized trials. PATIENTS AND METHODS: We analyzed sHER2 and tissue HER2 (tHER2) data from 1,902 patients (84%) who were randomly assigned to receive lapatinib or control in the trials EGF30001, EGF30008, and EGF100151. Cox regression analyses were performed to correlate both biomarkers with progression-free survival (PFS) and overall survival (OS)...
March 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Caihua Liang, Ling Li, Cindy Duval Fraser, Amy Ko, Deyanira Corzo, Cheryl Enger, Debra Patt
BACKGROUND: nab-Paclitaxel is an albumin-bound formulation of paclitaxel approved for the treatment of metastatic breast cancer (MBC). This analysis was designed to characterize the treatment patterns, efficacy, and safety of nab-paclitaxel for MBC treatment using health claims data from US health plans associated with Optum. METHODS: Women aged ≥ 18 years who initiated nab-paclitaxel for MBC treatment from January 1, 2005, to September 30, 2012, and who met eligibility criteria were selected from the Optum Research Database for this analysis...
2015: BMC Cancer
Henry L Gómez, Silvia Neciosup, Célia Tosello, Max Mano, José Bines, Gustavo Ismael, Patrícia X Santi, Hélio Pinczowski, Yeni Nerón, Marcello Fanelli, Luis Fein, Carlos Sampaio, Guillermo Lerzo, Adolfo Capó, Juan J Zarba, César Blajman, Mirta S Varela, Jeovany Martínez-Mesa, Gustavo Werutsky, Carlos H Barrios
BACKGROUND: Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2(+)) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. PATIENTS AND METHODS: In the present phase II, multicenter study, patients with HER2(+) MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m(2) on days 1 to 14 (LC), vinorelbine (V), 25 mg/m(2) on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m(2) on days 1 and 8 (LG), every 21 days...
February 2016: Clinical Breast Cancer
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